Label: HEMORRHOIDAL RELIEF CREAM- lidocane and glycerin cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 8, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • INDICATIONS & USAGE

    Uses

    • For temporary relief of pain, soreness and burning
    • Helps relieve the local itching and discomfort associated with hemorrhoids
    • Temporarily provides a coasting for relief of anorectal discomforts
    • Temporarily portects the inflamed irritated anorectal surface to help make bowel movements less painful
  • WARNINGS

    Warnings

    For External use only

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying this cream.
    • Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement.
    • Children under 12 years of age, ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients: Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Purified Water, Triethanolamine, vitamin E Acetate

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Lidocaine 5%...............................Local anesthetic

    Glycerin 14.4%............................Protectant

  • PURPOSE

    Protectant

    Local anesthetic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding

    • Ask a health professional before use.

  • STOP USE

    Stop use and ask a doctor if

    • Rectal bleeding occurs
    • Condition worsens or does not improve within 7 days
    • An allergic reaction occurs
    • The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.


    If pregnant or breast-feeding, ask a health professional before use.

  • WHEN USING

    When using this product

    • Do not exceed the recommended daily dosage unless directed by a doctor
    • Do not put this product into the rectum by using fingers or any mechanical device or applicator
  • PRINCIPAL DISPLAY PANEL

    Box

    Tube

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL RELIEF CREAM 
    lidocane and glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN4.032 g  in 28 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE1.4 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-333-011 in 1 BOX09/08/2021
    1NDC:51316-333-2828 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/08/2021
    Labeler - CVS Pharmacy, Inc (062312574)
    Registrant - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.805617610manufacture(51316-333)